MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number RMS-060026-R

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Activation Failure (3270)

Patient Problems Fever (1858); Pain (1994); Obstruction/Occlusion (2422); Hematuria (2558); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2018

Event Type  Injury  

Event Description

Kang 2018, application of resonance metallic stents for malignant ureteral obstruction."resonance metallic stents were placed first.All inserted stents had a diameter of 6 fr and a length of 26 cm.For retrograde stent insertion, the patient was placed in a lithotomic position under general anesthesia.A guide wire was inserted into the pelvis using ureteroscope and digital subtraction angiography (dsa), followed by inserting a coaxial system, an outer introducer sheath and an inner ureteral catheter.The resonance stent was then pushed through the outer sheath by using the inner catheter after removing it with the guide wire.After confirming that the proximal curl was formed in the renal pelvis, the introducer sheath was retrieved with the pusher catheter held in place until the distal pigtail curl was deployed in the bladder.For patients with previous nephrostomy, antegrade insertion was performed through the existing tract and a similar technique of retrograde approach was used.For the remaining patients, a standard pcn technique is performed and a percutaneous tract is established first." bilateral stents in one patient (7%) failed to achieve primary patency as she suffered fever, hematuria, flank pain, increasing creatinine and oliguria even after using diuretic with the stents in situ on the day after surgery.We had to extract both stents and performed ureterocutaneostomy instead rather than pcn, as per request of the patient.Extract both stents and performed ureterocutaneostomy.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 03-feb-2023.

Manufacturer Narrative

Device evaluation: the rms-060026-r device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms-060026-r devices are subject to visual a visual inspection and functional checks to ensure device integrity.Review of historical data: historical data was not reviewed as the lot number is unknown.Per the instructions for use (ifu0020) states the following potential events: diminished urine drainage/ stent occlusion, loss of renal function, pain/discomfort, hydronephrosis, stent dislodgement / migration" it should also be noted that the instructions for use (ifu0020) states the following: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to patient pre-existing conditions.It is know that the patient suffered from bilateral malignant ureteral obstruction and cervical carcinoma.These pre-existing conditions may have been the reasons for possible compression of the device, causing the stent to fail to maintain/ achieve patency.Summary: the failure to achieve stent patency was identified from the available information.A possible root cause is attributed to patient pre existing conditions.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient required surgical intervention due to the occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Device evaluation the rms-060026-r device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records review: manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms-060026-r devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Per the instructions for use (ifu0020) states the following: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause review root cause analysis: a definitive root cause could not be determined from the available information.However, as per medical advisory input it has been confirmed that the issue reported was a direct result of the patient pre-existing condition and not a failure of the device.Should more information become available the investigation will be updated accordingly.Confirmation of complaint: complaint is not confirmed due to no verifiable failure identified with the device.Summary bilateral stents in one patient failed to achieve primary patency.A definitive root cause could not be determined from the available information.However, as per medical advisory input it has been confirmed that the issue reported was a direct result of the patient pre-existing condition and not a failure of the device.Should more information become available the investigation will be updated accordingly.According to the initial reporter, the patient required surgical intervention due to the occurrence however as per medical advisory input it has been confirmed that the issue reported was a direct result of the patient pre-existing condition and not a failure of the device.As per d00213689, rev 006, section 5.3 table 01 ¿ product complaint is not confirmed as there is no verifiable failure identified with the device.Complaints of this nature will continue to be monitored for potential similar events.

Event Description

Supplemental correction report is being submitted following a review of this complaint file on (b)(6) 2024.Annex codes and investigation conclusions have been updated accordingly.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 15409511
• MDR Text Key: 299769623
• Report Number: 3001845648-2022-00629
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female